[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84578-84583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24503]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2024-0057; FRL-11683-09-OCSPP]
Certain New Chemicals; Receipt and Status Information for
September 2024
AGENCY: Environmental Protection Agency (EPA).
[[Page 84579]]
ACTION: Notice.
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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA Section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 9/1/
2024 to 9/30/2024.
DATES: Comments identified by the specific case number provided in this
document must be received on or before November 22, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2024-0057, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Jim Rahai, Project Management
and Operations Division (MC 7407M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-8593; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
This document provides the receipt and status reports for the
period from 9/1/2024 to 9/30/2024. The Agency is providing notice of
receipt of PMNs, SNUNs, and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.
B. What is the Agency's authority for taking this action?
Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.
Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as
appropriate, before initiating the activity. EPA will review the
notice, make a risk determination on the chemical substance or
significant new use, and take appropriate action as described in TSCA
section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: https://www.epa.gov/chemicals-under-tsca.
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.
C. Does this action apply to me?
This action provides information that is directed to the public in
general.
D. Does this action have any incremental economic impacts or paperwork
burdens?
No.
E. What should I consider as I prepare my comments for EPA?
1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
[[Page 84580]]
II. Status Reports
In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending, or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (see the Federal
Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.
III. Receipt Reports
For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.
Table I--PMN/SNUN/MCANs Approved From 9/1/2024 to 9/30/2024
----------------------------------------------------------------------------------------------------------------
Received
Case No. Version date Manufacturer Use Chemical substance
----------------------------------------------------------------------------------------------------------------
P-20-0174A.......... 7 08/29/2024 P2 Science, Inc.... (S) For use in (S) 6-Octen-1-ol, 3,7-
consumer products, dimethyl-, homopolymer,
as well as direct monoacetate.
addition to
consumer products.
Specific functions
would be as
solubilizer,
rheology modifier
and fragrance oil.
The candidate
substance is
expected to be
used as an
ingredient in the
formulation of a
broad range of
consumer products
including but not
limited to laundry
detergents,
cleaners, fabric
softeners, air
fresheners, etc.
In addition, it is
anticipated to be
added as an
ingredient to
fragrances by
fragrance
manufacturers, who
will then supply
these fragrances
to downstream
consumer product
companies to use
in the manufacture
of their goods.
The anticipated
range of use
levels is 0.1-5.0%.
[[Page 84581]]
P-20-0184A.......... 5 08/29/2024 P2 Science, Inc.... (S) For use in (S) 6-Octen-1-ol, 3,7-
fragrances for dimethyl-, homopolymer.
consumer products,
as well as direct
addition to
consumer products.
Specific functions
would be as
solubilizer,
rheology modifier
and fragrance oil
The candidate
substance is
expected to be
used as an
ingredient in the
formulation of a
broad range of
consumer products
including but not
limited to laundry
detergents,
cleaners, fabric
softeners, air
fresheners, etc.
In addition, it is
anticipated to be
added as an
ingredient to
fragrances by
fragrance
manufacturers, who
will then supply
these fragrances
to downstream
consumer product
companies to use
in the manufacture
of their goods.
The anticipated
range of typical
use levels is 0.1-
5.0%.
P-22-0158A.......... 4 09/06/2024 Aqdot.............. (G) Additive used (S) 1H,4H,14H,17H-
in consumer, 2,16:3,15-Dimethano-
commercial, and 5H,6H,7H,8H,9H,10H,11H,1
industrial 2H,13H,18H,19H,20H,21H,2
applications. 2H,23H,24H,25H,26H-2,3,4
a,5a,6a,7a,8a,9a,10a,11a
,12a,13a,15,16,17a,18a,1
9a,20a,21a,22a,23a,24a,2
5a,26a-
*tetracosaazabispentalen
o[1''',6''':5'',6'',7'']
cycloocta[1'',2'',3'':3'
,4']pentaleno[1',6':5,6,
7]cycloocta[1,2,3-
gh:1',2',3'-
g'h']cycloocta[1,2,3-
cd:5,6,7-
c'd']dipentalene-
1,4,6,8,10,12,14,17,19,2
1,23,25-dodecone,
dodecahydro-,
stereoisomer;2,18:3,17-
Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10
a,11a,12a,13a,14a,15a,17
,18,19a,20a,21a,22a,23a,
24a,25a,26a,27a,28a,29a,
30aoctacosaazabispentale
no[1''''',6''''':5'''',6
'''',7'''']cycloocta[1''
'',2'''',3'''':3''',4'''
]pentaleno[1''',6''':5''
,6'',7'']cycloocta[1'',2
'',3'':3',4']pentaleno[1
',6':5,6,7]cycloocta[1,2
,3-cd:1',2',3'-
gh]pentalene-
1,4,6,8,10,12,14,16,19,2
1,23,25,27,29-
tetradecone,
tetradecahydro-,
stereoisomer;2,20:3,19-
Dimethano-
2,3,4a,5a,6a,7a,8a,9a,10
a,11a,12a,13a,14a,15a,16
a,17a,19,20,21a,22a,23a,
24a,25a,26a,27a,28a,29a,
30a,31a,32a,33a,34adotri
acontaazabispentaleno[1'
'''',6''''':5'''',6'''',
7'''']cycloocta[1'''',2'
''',3'''':3''',4''']pent
aleno[1''',6''':5'',6'',
7'']cycloocta[1'',2'',3'
':3',4']pentaleno[1',6':
5,6,7]cycloocta[1,2,3-
gh:1',2',3'-
g'h']cycloocta[1,2,3-
cd:5,6,7-
c'd']dipentalene-
1,4,6,8,10,12,14,16,18,2
1,23,25,27,29,31,33-
hexadecone,
hexadecahydro-,
stereoisomer.
P-23-0117A.......... 6 09/04/2024 Braven (S) Feedstock (G) Waste plastics,
Environmental, LLC. blended into fuels pyrolyzed, condensate.
and fuel
blendstocks;
Chemical feedstock.
P-23-0138A.......... 2 08/27/2024 CBI................ (S) Photoinitiator: (S) Benzoic acid, 2-
Amine Synergists ([1,1'-biphenyl]-4-
or Amine Acrylates ylcarbonyl)-, 2-
like OPV and ethylhexyl ester.
industrial
coatings
(pigmented systems
like offset, flexo
and inkjets) No
domestic
production as this
product is for
import only.
P-23-0149A.......... 4 09/20/2024 CBI................ (S) This material (G) Dialkyltin Fatty
is a catalyst. acids ester.
P-23-0189A.......... 2 09/06/2024 CBI................ (G) Component in (G)
polymers. Dimethanocarbopolycycle,
alkyl-polyhydro-.
P-23-0189A.......... 3 09/10/2024 CBI................ (G) Component in (G)
polymers. Dimethanocarbopolycycle,
alkyl-polyhydro-.
P-24-0086A.......... 2 09/24/2024 HydroGraph......... (S) Thermosets a. (S) few layer, non-
Automotive parts: functionalized,
Used to turbostratic graphene in
manufacture a powdered form of
various automotive aggregated nano-
components, such platelets from carbon-
as brake pads, rich gas explosion
engine mounts, synthesis.
electrical
connectors, and
interior trim, due
to their excellent
heat resistance
and mechanical
properties.
[[Page 84582]]
P-24-0087A.......... 2 09/24/2024 HydroGraph......... (S) Alternative (S) few layer, non-
energy: Wind functionalized,
blades and solar turbostratic graphene in
panels, a powdered form of
Construction aggregated nano-
materials platelets from carbon-
including rich gas explosion
concrete, asphalt, synthesis.
and other
engineered
materials.
P-24-0104A.......... 6 09/12/2024 CBI................ (G) Plastic (G) carbomonocycle
additive. alkylamide, 3,5-bis(1,1-
dialkyl)-N-[2,5-dioxo-3-
(polyalkylene)-1-
heteromonocyclic]- -4-
hydroxy-.
P-24-0158A.......... 3 09/03/2024 CBI................ (G) Resin for (G) Polyhydroxyalkanoate.
packaging, battery
technology.
P-24-0186A.......... 3 09/04/2024 SGP Ventures, Inc.. (S) Epoxy used to (S) 2-Oxiranemethanamine,
fill holes in N-[2-methyl-4-(2-
printed circuit oxiranylmethoxy)phenyl]-
boards. N-(2-oxiranylmethyl)-.
P-24-0192A.......... 4 09/23/2024 Bruhl Chemical (S) Paints, (S) 4-
Trade, Inc. coatings and inks. Hydroxybenzophenone,
ethoxylated, esters with
acrylic acid.
P-24-0192A.......... 5 09/26/2024 Bruhl Chemical (S) Paints, (S) poly(oxy-1,2-
Trade, Inc. coatings and inks. ethanediyl), alpha-(1-
oxo2-propen-1-yl)-omega-
(4-benzoylphenoxy)-.
P-24-0193........... 1 09/13/2024 CBI................ (G) Dispersive Use. (G) Perfluorosulfonic
acid polymer, with
perfluorodioxolane.
P-24-0195........... 1 09/26/2024 CBI................ (G) Heat transfer (G) Trimers of
fluid, Dielectric hexafluoropropene.
testing.
SN-22-0006A......... 4 08/30/2024 MacDermid Enthone, (G) Catalyst (S) Tungstate
Inc. (contained use). (W12(OH)2O386-), sodium
(1:6).
SN-22-0006A......... 5 09/16/2024 MacDermid Enthone, (G) Catalyst (S) Tungstate
Inc. (contained use). (W12(OH)2O386-), sodium
(1:6).
SN-22-0007A......... 8 09/04/2024 Braven (G) Product of (S) Waste plastics,
Environmental, LLC. Pyrolysis pyrolyzed, C5-12
manufacturing. fraction.
SN-22-0008A......... 9 09/04/2024 Braven (G) Product of (S) Waste plastics,
Environmental, LLC. Pyrolysis pyrolyzed, C20-55
Manufacturing. fraction.
SN-22-0009A......... 8 09/04/2024 Braven (G) Product of (S) Waste plastics,
Environmental, LLC. Pyrolysis pyrolyzed, C9-20
Manufacturing. fraction.
----------------------------------------------------------------------------------------------------------------
In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was received by
EPA, the date of commencement provided by the submitter in the NOC, a
notation of the type of amendment (e.g., amendment to generic name,
specific name, technical contact information, etc.) and chemical
substance identity.
Table II--NOCs Approved From 9/1/2024 to 9/30/2024
----------------------------------------------------------------------------------------------------------------
Received Commencement If amendment, type
Case No. date date of amendment Chemical substance
----------------------------------------------------------------------------------------------------------------
P-18-0014A....................... 09/09/2024 04/22/2024 Revised specific (G) Sulfonium, triphenyl-
chemical name. , salt with
disubstituted-
heterocyclic compound
(1:1).
P-19-0095A....................... 09/12/2024 03/26/2024 Revised generic (G) Alkane, mixed with
chemical name. carbon dioxide and
oxygen, fermented,
hydroxyalkanoic acid
homopolymer.
P-19-0173........................ 09/05/2024 09/05/2024 N................... (S) Benzoic acid, 2,4-
dichloro-5-fluoro-.
P-19-0175........................ 09/06/2024 09/06/2024 N................... (S) Benzoic acid, 5-
chloro-2-methyl-.
P-19-0182........................ 09/05/2024 09/05/2024 N................... (S) Benzoic acid, 2,4-
dichloro-5-fluoro-,
sodium salt (1:1).
P-19-0184........................ 09/06/2024 09/06/2024 N................... (S) Benzoic acid, 5-
chloro-2-methyl-,
sodium salt (1:1).
P-20-0122A....................... 09/09/2024 04/22/2024 Revised generic (G) Heterocyclic onium
chemical name. compound with
fluorosubstitutedalkyl
2-methyl-2-propenoate
(1:1), polymer with
acenaphthylene, 4-
ethenyl-alpha,alpha-
dimethylbenzenemethanol
and 4-ethenylphenyl
acetate, hydrolyzed.
P-21-0002........................ 09/18/2024 12/20/2022 N................... (G) Octadecanoic acid,
12-hydroxy-, polymer
with aziridine, 2-
oxepanone and
tetrahydro-2H-pyran-2-
one, reaction products
with disubstituted
heteropolycycle.
P-21-0034........................ 09/26/2024 09/14/2024 N................... (G) Polymer modified
multifunctional silane.
P-22-0137A....................... 09/17/2024 09/10/2024 N................... (G) Aklyl dialkylamine.
P-22-0138........................ 09/17/2024 09/16/2024 N................... (G) Tetraalkylammonium
chloride.
P-23-0032........................ 09/26/2024 09/12/2024 N................... (S) 1, 3-propanediol,
polymer with 1, 3-
diisocyanatomethylbenze
ne.
P-23-0102........................ 09/18/2024 09/01/2024 N................... (G) Glycerides from
fermentation of
genetically modified
microorganism.
P-23-0134........................ 09/12/2024 08/14/2024 N................... (S) Poly[oxy(methyl-1,2-
ethanediyl)],alpha-
hydro-omega-{[2-[(1-
chloro-9-oxo-9H-
thioxanthen-4-
yl)oxy]acetyl]oxy{time}
-,ether with 2,2-
bis(hydroxymethyl)-1,3-
propanediol (4:1).
P-23-0142........................ 09/27/2024 09/26/2024 N................... (G) Alkenal, 9-
(acetyloxy)-, (E)-.
P-23-0160........................ 09/04/2024 08/26/2024 N................... (G) Alkenoyl chloride, 3-
methyl-.
P-23-0170........................ 09/04/2024 08/19/2024 N................... (G) Ethanaminium, 2-[3-
(2,5-dioxo-1-
heteromonocyclic)
propoxy]-N,N,N-
trimethyl-,
monopolyisobutylene
derivs., Me
ethanedioate.
P-24-0005........................ 09/12/2024 08/26/2024 N................... (S) [[1,1'-biphenyl]-
4,4'-diol, reaction
products with 4-
cyclohexylphenol and
2,4,6-trichloro-1,3,5-
triazinec.
----------------------------------------------------------------------------------------------------------------
In Table III of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information that has been received during this time period: The
EPA case number assigned to the test information; the date the test
information was received by EPA, the
[[Page 84583]]
type of test information submitted, and chemical substance identity.
Table III--Test Information Received From 9/1/2024 to 9/30/2024
----------------------------------------------------------------------------------------------------------------
Received
Case No. date Type of test information Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712.................... 09/26/2024 Polychlorinated Dibenzodioxins (S) Waste plastics, pyrolyzed, C5-
and Polychlorinated 55 fraction.
dibenzofurans Testing.
P-16-0543.................... 09/24/2024 Exposure Monitoring Report....... (G) Halogenophosphoric acid metal
salt.
P-21-0180.................... 09/18/2024 Determination of Water Solubility (G) Sulfonium,
Report. (halocarbomonocycle)diphenyl-,
salt with 1-heterosubstituted-2-
methylalkyl trihalobenzoate
(1:1).
P-22-0086.................... 09/26/2024 Supplementary Test Data Report... (G) Phenoxathiinium, 10-phenyl-,
5-alkyl-2-alkyl-4-(2,4,6-
substituted tri- carbopolycycle,
hetero-acid)benzenesulfonate
(1:1).
P-22-0179.................... 09/18/2024 Water Solubility: Column Elution (G) Sulfonium,
Method; Shake Flask Method (OECD (alkylsubstitutedphenyl)diphenyl-
Test Guideline 105). , salt with 1-
(heterosubstitutedalkyl)-2,2,2-
triheterosubstitutedalkyl
trisubstitutedbenzoate (1:1).
P-22-0180.................... 09/18/2024 Water Solubility: Column Elution (G) Dibenzothiophenium, 5-phenyl-
Method; Shake Flask Method (OECD , 4-[1-(heterosubstitutedalkyl)-
Test Guideline 105). 2,2,2-
triheterosubstitutedalkoxy]-4-
oxoalkyl trisubstitutedbenzoate
(1:1).
P-24-0097.................... 09/18/2024 Water Solubility: Column Elution (G) Sulfonium, tris(4-
Method; Shake Flask Method (OECD fluorophenyl)-,
Test Guideline 105). (substitutedphenoxy)alkyl
substitutedbenzoate (1:1).
----------------------------------------------------------------------------------------------------------------
If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.
Authority: 15 U.S.C. 2601 et seq.
Dated: October 17, 2024.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2024-24503 Filed 10-22-24; 8:45 am]
BILLING CODE 6560-50-P